Wonder Women of Medtech

June 22, 2017

Tasked with completely revamping patient perception of mammography, GE Healthcare's AurelieBoudierfound a way to put women in control of their own exam, under the guidance of a technologist. Boudier, global creative director of brand and design language for the company’s global design department, also made patient comfort a priority when she designed the SenographePristina.

“Pristina has the best of our technology, but it was also inspired by empathy with women,” she said.

According to GE, the system is the industry’s first self-compression mammography tool. Pristina is operated by a remote control that allows women to adjust the amount of compression pressure they experience during the exam.

“We know that compression can be painful,” Boudier said. “This device is more comfortable and the design helps improve patient comfort during detection.”

The detector is thinner than conventional mammography systems and features rounded corners so less of the device comes in contact with the woman’s bare skin. The system also positions women in a way that allows them to lean comfortably on the armrests, GE said, relaxing the muscles to simplify image acquisition. Traditionally, women are positioned in a way that projects stress on the handles of the machine, which tenses pectoral muscles and impacts image quality.

The design team worked closely with patients, technologists, and radiologists from GustaveRoussy Cancer Center in Paris, France to address concerns of both clinicians and patients.

Boudier also made sure the SenographePristina incorporated a soft, metallic pink color, or a more mature pink, as she described it. “It’s not Hello Kitty or Barbie pink,” she said.

So far, GE said, clinicians and patients have responded favorably to the new design.

“I know that our team did our job if more women are going for their annual mammograms and aren’t scared to walk into the room and do the exam,” Boudier said. “It’s such an important part of maintaining a healthy life, and I want it to be a less painful experience for women around the world.”

Victoria Carr-Brendel has over 25 years of medical device experience, including the development and commercialization of medical device products across disease states, from diabetes to peripheral vasculature and electrophysiology. Currently, Carr-Brendel is the CEO at JenaValve Technology Inc., an up-and-coming player in the transcatheter aortic valve replacement (TAVR) market.

Carr-Brendel recently answered the following questions for Qmed about the medical device field and her role in the industry.

What attracted you to the medtech field?

It's funny, since I was in seventh grade I knew I wanted to go into research. As I completed my higher education degrees, I realized I wanted to make a difference in patient lives. Whether it was through generating technology that saved lives, increased the lifespan of patients, or improved their quality of life, I needed to pick a field that could enable that. Therefore, medtech satisfied the ability to make a difference in a timely fashion to achieve those objectives, vs. adding your piece of information to the information pie, and collectively improving the knowledge of the field. I believe medtech is special. It enables you to change the way medicine is being practiced, but not have to be a physician to do so. Lastly, we as Americans have to solve the problem of ever-increasing healthcare costs, and in the last decade, I have added that requirement to anything I want to be affiliated within medical devices. Ultimately, we have a responsibility to make sure the technology we offer enables healthcare cost savings, whether it is through fewer follow-up visits to the doc, fewer acute events, alternatives to costly surgery with a minimally invasive option, etc. In that way, medtech is a very special field, and if everyone knew how cool it was, they would all want to be doing it.

What do you find most rewarding about working in this industry?

I covered this above, but most certainly it is changing the way medicine is being practiced by creating technology that literally improves the care of patients in a cost-effective fashion. I once was sitting at my son’s little league game and a patient was describing a life-changing product for the way he treated his disease, and after a few more sentences, I realized it was a product I had helped develop. It gives you chills to realize it is not figurative or abstract, it really makes a difference, and patients feel it every day.

What do you find most challenging about working in this industry?

The greatest challenge is how long it takes to get class III/PMA level medical devices (the most strict category of regulatory approval) approved throughout the world. I realize the various regulatory bodies have to protect the interests of the sick, but it can be overly restrictive when patients are literally dying because the alternative therapy has so much risk. For example, the United States was way behind in approving transcatheter heart valve therapy, relative to other countries, despite the known improvements in outcomes for those patients (e.g. shorter hospital stays and getting back to work quicker) compared to conventional, open heart surgery. How can the United States be behind at least 50 other countries in approving that therapy? U.S. patients deserve best-in-class treatments, and the burden to be able to offer that to U.S. patients cannot be so restrictive when other countries have found it to be sufficiently safe. We do not need other countries to become more conservative, we need the United States to become less conservative.

Who is someone in the medtech/diagnostics industry that you consider a role model for other women in the industry, and why?

I actually think we need to go outside the medtech/diagnostics industry for a role model for other women. Unfortunately, I do not know of many women in the medtech industry that it could be argued are making a global impact. Many are making a great impact on their companies and culture, but there are so few of us leading medtech companies. I would argue that although it seems to be going out of fashion, Sheryl Sandberg and her lean-in concept was a conversation that needed to be held. Women need to embrace and lean into challenges and start saying “yes” instead of limiting their growth by self-inflicted doubts and characterization of strengths/weaknesses. That, in combination with great sponsors of women, will change the face of our industry and allow more women to lead, and finally, give us a selection to fill in a name for the answer to this question.

Lisa Earnhardt is CEO and president of Intersect ENT, a position she has held since 2008. Previously, Earnhardt was president of Boston Scientific’s cardiac surgery division. She has more than two decades of experience in healthcare, primarily in leading global product launches and driving adoption of new medical technologies at both Boston Scientific and Guidant in a variety of sales and marketing leadership roles.

In addition to Intersect ENT, Earnhardt serves on the board of directors for AdvaMed, the advisory board for Kellogg Global, and the Young Presidents' Organization.

After working in the medical device and life sciences industries for more than 15 years throughout the world, Marissa Fayer decided her passion is helping companies achieve growth strategies. She founded Fayer Consulting Associates to execute on that passion.

Fayer previously was CEO and founder of HERHealthEQ, a non-profit organization that provides medical devices and equipment to small regions in developing nations through programs that instill access to education and healthcare as a means to enforce social and gender equality.

She also has been director of business development at Asclepius Life Sciences, an organization focused on robust investment opportunities in the life sciences sector.

Gabriele G. Niederauer, is CEO and president of Bluegrass Vascular Technologies (BVT)., a company she joined in September 2014 to help commercialize the Surfacer Inside-Out Access System. The Surfacer System, which is available in Europe, is designed with an "inside-out" approach to gain central venous access. The device was developed to allow physicians to maintain access in an occluded vein and eliminate the need to compromise an additional vein.

Prior to BVT, Niederauer was senior vice president of technology and development and a founding officer of ENTrigue Surgical, where she developed and commercialized five sinus surgery products. That company was acquired in 2013 by ArthoCare Corporation, which was subsequently bought by Smith & Nephew.

Niedarauer recently answered the following questions for Qmed about the medical device field and her role in the industry.

What attracted you to the medtech field?

My father, also an engineer, manufactured one of the first alumina hip implants in Germany, where I was raised. I’m sure that planted an early seed. In my senior year of college, I realized biomedical engineering would allow me to make products to help people and that medtech was my calling.

What do you find most rewarding about working in this industry?

Having one of your products used to successfully treat a patient. For our first Surfacer System case in Europe, the product saved the patient’s life. Those are lifetime moments. In my medtech career, I’ve had a few patients contact me directly to share how a product changed their quality of life. Those are conversations I’ve never forgotten, and they fuel me when I need motivation.

What do you find most challenging about working in this industry?

The steps needed to take a concept to full commercial use are getting harder and take longer every year due to changing regulations, tougher reimbursement criteria, etc. Patience and perseverance are important traits needed to survive those challenges.

Who is someone in the medtech/diagnostics industry that you consider a role model for other women in the industry, and why?

VC Investor Jeanette Welsh, partner and chief administrative officer at Telegraph Hill Partners, is a minority in the venture capital world. Being an attorney by training, she has helped me through many challenges and provided guidance on fundraising and negotiations.

Cathy Burzik, a former CEO of Kinetic Concepts Inc. During that tenure, she was the only female CEO of the top 10 U.S. medical device companies. Cathy is extremely well connected and I could always count on her to open a door for me when I needed an introduction to another company or funding source.

Isabelle Noblanc is the vice president and general manager of UL Compliance to Performance. She is at the helm of a company that is having a massive influence on helping medical device and pharmaceutical companies assure compliance while building a path to higher performance. This helps them enter new markets and get to market faster.

Beyond serving clients, she has developed a unique partnership with FDA where her people provide online training for more than 35,000 federal, state, local, and global investigators in the areas of quality and compliance. In other words, they train the FDA investigators that audit medical device and drug companies.

Noblanc recently answered the following questions for Qmed about the medical device field and her role in the industry.

What attracted you to the medtech field?

Like many, my personal life and experiences have played an important role in my attraction to medtech. I grew up reading my father’s medical magazines, and being driven by the desire to help people be healthier. I also lost my partner to cancer and realized that, even though we have made much progress, we have much more to accomplish in areas of disease detection, drug delivery, etc. I have been fortunate to join UL, a safety science, mission-driven company, and to be able to focus on helping the medtech industry achieve both sustainable compliance, and operational excellence.

What do you find most rewarding about working in this industry?

Medtech is an industry that changes continuously, driven by the common desire of its members to improve human health. Most people have either personal stories or a profound personal motivation that drove them to this industry. There is a level of passion, dedication, and commitment that exists in very few industries. Working side by side with such people and helping improve human and animal health together is what gets me up in the morning

What do you find most challenging about working in this industry?

What is challenging about working in this industry is the feeling of being pulled in two opposite directions, the constant balance between ensuring regulatory compliance and fostering innovation. Both are absolutely necessary to the industry, and they require medtech companies to define their strategies, governance, processes, and systems with the precision of a surgeon to ensure that risk management and agility can coexist.

Who is someone in the medtech/diagnostics industry that you consider a role model for other women in the industry, and why?

I admire strong female executives such as Luann Pendy, who leads Medtronic's global quality operations with passion and energy, and is one of the company's leaders who champion Medtronic’s "Women in Science and Engineering” initiative. I also admire entrepreneurs like Edel Browne, who decided at age 15 that she wanted to do something to manage freezing gait in Parkinson's patients and is now, at age 19, seeking crowdfunding for her second prototype laser light device and patient testing. Passion, the desire to make a difference, and the courage to execute on it are the ingredients that make someone a role model.

Stacey Pugh leads Medtronic's Neurovascular business, which is part of the company's Restorative Therapies Group. She started her career as a nurse, and has been instrumental in the design and implementation of the global clinical trials that led to the 2015 AHA/ASA updated guidelines to recommend the use of stent retriever technology.

Pugh recently answered the following questions for Qmed about the medical device field and her role in the industry.

What attracted you to the medtech field?

I started my career as a critical care nurse, with a mission to make an impact on people’s lives. I didn’t originally plan to end up working for the medtech industry, but when my role as a nurse evolved to working on clinical trials, I began to see the impact that the industry could have on the healthcare system. I also realized that even when patients are being provided the best care, there are still many things for which we don’t have a good answer. At that time, the heartbreak I experienced caring for a young patient who was suffering from acute respiratory distress system (ARDS), for whom we could do very little, made me realize I wanted to move patient care forward on a higher level.

When running clinical affairs at Texas Tech, I had the opportunity to collaborate closely with the medtech industry and recognized the exponential capability the industry had to advance clinical therapy and tackle unmet needs with medical technology. That collaboration led me to a clinical affairs positions with Kinetic Concepts, Covidien, and Medtronic.

What do you find most rewarding about working in this industry?

Being a nurse is at the core of who I am, so much so that I continue to maintain my nursing license, though I am not sure who would hire me! I also found that I have a love for the business world. I can combine both of those every day and that is the most rewarding part of the work that I do today. I have never felt that I was out of reach of having an impact on patients, nor have I ever found my commitment to patient care to conflict with my work at Medtronic, and that’s a beautiful thing. The progression in science is extraordinary, and it aligns so closely with my initial career mission: to develop and improve patient care to the best of my ability.

As I think about the work Medtronic did in stroke research with our Solitaire device, I can appreciate how we were able to have an impact on stroke care at a level that I could never have achieved as a single clinician.

In addition, Medtronic takes its commitment to diversity in leadership very seriously, and I’m so fortunate to have the opportunity to work with developing future leaders through Medtronic’s Women’s Network, an initiative focused on developing female leaders in the industry. The more experience I get in my own career, the more rewarding developing future leaders becomes. Promoting female leadership is something I grow more and more passionate about every day as I see the benefits of all kinds of diversity in my leadership team.

What do you find most challenging about working in this industry?

Innovation moves quickly, but the evolution of healthcare today moves more quickly. Increasingly, the global nature of our business finds us with more stakeholders, more complex markets, and greater pressures on healthcare value. This is the most rewarding and most challenging part of our job. I had a boss who continually reminded me that if the pace of change outside of your business is greater than that inside your business, the end is near. In general, I think that change management is the seminal leadership challenge that most of us face in medtech today.

We also cannot ignore that it is still a male-dominated business, even though the number of female leaders is growing. There have been times where I was mistaken for a secretary when dining with a group of my male peers or found myself presenting to an audience of more than 100 men, not a woman in sight. These experiences remind me how important it is to continue to mentor and support to women in medtech.

Who is someone in the medtech/diagnostics industry that you consider a role model for other women in the industry, and why?

Without a doubt, Stacy Enxing Seng was a huge role model for me when we worked together at Covidien, and I consider her an excellent role model for any woman in the medtech industry. Stacy was the first woman with whom I interacted that I really saw as a leader in the medical device industry. It was clear that a big part of her success was that she was always passionate about her work. It was joyful for her. Stacy was not afraid to lead in her own way, and working with her inspired me to do the same.

One day, Stacy gave me advice I will never forget: “When they ask you what you want, and they will, you better have an answer.” When the time inevitably came that I was asked what I wanted, I had taken her advice to heart and had a very clear answer prepared. The opportunity that arose, to lead Medtronic’s neurovascular business in the EMEA, was a critically important step in my career. Women are sometimes concerned about appearing arrogant or overly assertive for saying “this is what I want,” so they don’t put themselves out there. Stacy’s guidance helped me be unafraid.

Martha Shadan is CEO of Rotation Medical, a company focused on improving the treatment of rotator cuff disease with technologies that biologically heal tendons. Shadan joined Rotation Medical in 2013, bringing more than three decades of marketing and commercialization expertise to her role as CEO. She has held senior executive positions in leading medical device companies, including president of the trauma division at Zimmer, vice president and general manager of vascular therapies and vice president and general manager of biosurgery and sports surgery at Covidien, and senior roles at Bristol Myers Squibb and EMD Millipore. She is a member of AdvaMed, sitting on the board of directors for the organization as well as its Accel division, and she is part of the leadership circle for its Women's Executive Network.

Shadan recently answered the following questions for Qmed about the medical device field and her role in the industry.

What attracted you to the medtech field?

What attracted me is probably similar to many others in this field: the ability to make people's lives better with the help of new and novel technologies.

What do you find most rewarding about working in this industry?

It is very gratifying to talk with patients who have received our technology and hear how they can now return to the quality of life they enjoyed before getting rotator cuff disease.

What do you find most challenging about working in this industry?

There is a decline in the VC investments in medtech. This is making it extremely challenging for small startups to find and attract capital investments.

Who is someone in the medtech/diagnostics industry that you consider a role model for other women in the industry, and why?

There is not one woman I can point to. I think there are multiple women who have a strong sense of themselves and have worked hard, despite challenges, to advance their careers.

Leslie Trigg is CEO of Outset Medical. Prior to Outset, she was executive vice president at Lutonix, a cardiovascular medical device company acquired by C.R. Bard.

Outset's dialysis technology and self-serve model could bring dialysis care into the consumer-product era of healthcare.

In a recent interview with Qmed, Trigg pointed out that dialysis treatment is one of the largest areas of healthcare that has been the least touched by new technology and service model innovation. "Patients today in the clinic are still served in essentially the same way they were back in the 1980s," she said.

Outset saw an opportunity to introduce a new type of dialysis technology and service model aimed at cost reduction for providers, and a better care experience for patients. The resulting product is a new kind of dialysis machine that could be compared to the Keurig coffee maker in that it offers a single-serving, dialysis-on-demand approach.

“It’s sort of the K-Cup of dialysis,” Trigg said.

Laura Dietch is CEO of BioTrace Medical Inc., an early stage cardiovascular device company. She has more than 25 years of experience in the medical device industry. Since 2002, she has provided high impact consulting services, offering both strategic and operational expertise to early stage technology companies as well as large public corporations.

Previously, Laura worked at Advanced Cardiovascular Systems during the rapid growth period from the mid '80s to the early '90s. She was then a member of the senior management team at Progressive Angioplasty Systems (acquired by US Surgical) and later LuMend (acquired by Johnson & Johnson). She was vice president of global marketing for Medtronic Vascular with worldwide responsibility for cardiovascular, peripheral vascular, neurovascular, and abdominal aortic aneurysm products, and was also a director of Vascular Cures, and a past chairperson of the board of directors of the Silicon Valley Division of the American Heart Association.